In the Federal Register Notice of March 2, 2020 (linked here), the United States Patent and Trademark Office (USPTO) published a guidance such that, effective immediately, it will be necessary to provide evidence that delays were unintentional for the following petitions:
In a recent case, Samsung Electronics America v. Prisua Engineering Corp., the Federal Circuit held that the Patent Trial and Appeal Board (PTAB) cannot invalidate patent claims as indefinite during an Inter Partes Review, making some patents more difficult to challenge.
Recently, the Supreme Court once again refused to take up cases involved in the 101 statute (patentable subject matter).
Many briefs were filed by the industry, academics, and the government to urge the Supreme Court to update and clarify what is patentable and what is not patentable. The refusal to intervene may be a signal to Congress that it should be up to them to decide on the matter.
The Safe Harbor Provision of 35 U.S.C. § 271(e)(1) states that:
“It shall not be an act of infringement to make, use, offer to sell, or sell within the United States or import into the United States a patented invention (other than a new animal drug or veterinary biological product which is primarily manufactured using recombinant DNA, recombinant RNA, hybridoma technology, or other processes involving site-specific genetic manipulation techniques) solely for uses reasonably related to the development and submission of information under a Federal law which regulates the manufacture, use, or sale of drugs or veterinary biological products.”
In a recent infringement case, Amgen v. Hospira, the allegedly infringed patents related to cells that stimulate the creation of red blood cells in anemia patients and a method of preparing erythropoietin (EPO).
In 2001, the U.S. Patent and Trademark Office (USPTO) issued a written description guideline in which it specified that one of skill in the art would have recognized that the spectrum of antibodies which bind to antigen X were implicitly disclosed as a result of the isolation of antigen X.
In a recent case, Idenix Pharmaceutical LLC v. Gilead Sciences Inc. (Fed. Cir. 2019), the Federal Circuit affirmed a decision from the District Court invalidating a patent for lack of written description and enablement.
A few weeks ago (mid-October 2019), the USPTO released an updated (view here) patent subject matter eligibility guidance (PEG) along with new examples related to personalized medicine, therapeutic methods, and pharmaceutical products.
The October update is essentially a clarification of the January 2019 guidance.
Finally, a few diagnostic method claims have been found patent eligible. This is not a Court decision, but rather a decision reached by the Patent Trial and Appeal Board (PTAB). The claims under the PTAB were:
Recently, in Mayo Foundation for Medical Education and Research v. Iancu, the Federal Circuit agreed with the U.S. Patent and Trademark Office (USPTO) with regard to the Patent Term Adjustment (PTA) for U.S. Patent No. 8,981,063. The issue was whether the interpretation of “any time consumed by continued examination of the application requested by the applicant” was correct.